Vaginal ProlapseNCT04701047
Prospective Observational Prolapse Study
An observational study of Vaginal Prolapse, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- vaginal pessary and Vaginal prolapse surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Sep 2021to Jan 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The research population will include women above the age of 18 years old who consult the department of urology or the department of gynaecology at the university hospital of Ghent with symptoms of vaginal prolapse. The patients will be recruited by their attending physician. There will be no exclusion on the degree of vaginal prolapse. All symptomatic prolapses will be included in this study. Exclusion criteria will be having undergone a previous treatment with a pessary or surgery for vaginal prolapse, contraindications for surgery or pessary use, active of passive child wish, not able to understand the Dutch language and not able to give a written consent.
Who may be able to join
- women with a symptomatic vaginal prolapse
- older than 18 years
Who cannot join
- under 18 years old
- undergone a previous treatment with a pessary or surgery for vaginal prolapse
- contra-indications for surgery or pessary use
- active or passive child wish
- not able to understand the Dutch language
- not able to give a written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Eline Meireson, 09/332 78 17, eline.meireson@uzgent.be
About this study
Official title: Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.
Read the detailed description
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.
The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.
The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.
The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.
- Conditions
- Vaginal Prolapse
- Being tested
- vaginal pessary, Vaginal prolapse surgery
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal pessaryDevice
insertion and follow up of a vaginal pessary
Vaginal prolapse surgeryProcedure or surgery
surgery and follow up after vaginal prolapse surgery
| Study group | Role | What they receive |
|---|---|---|
| pessary | Vaginal prolapse being treated by pessary Receives: Device: vaginal pessary | |
| surgery | Vaginal prolapse being treated by surgical repair Receives: Procedure: Vaginal prolapse surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic Floor Disability Index (PFDI-20)
Change in scores on the short-form version of the Pelvic Floor Distress Inventory (PFDI). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.
Measured: Baseline, 6 weeks, one year, two years, five years
Change in pelvic floor impact questionnaire (PFIQ-7)
Change in scores on the shortened version of the Pelvic Floor Impact Questionnaire (PFIQ). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.
Measured: Baseline, 6 weeks, one year, two years, five years
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Change in scores on the short form of the PISQ-31 that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse
Measured: Baseline, 6 weeks, one year, two years, five years
Secondary outcomes (6)
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
Study participants are asked how satisfied they are with their pessary use at 4 months after the initiation of pessary use. Participants can choose one of five graded answers on the Likert scale:
5 Very satisfied 4 satisfied 3 neutral 2 unsatisfied
1 very unsatisfied
Measured: 4 months after start of therapy
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
Study participants are asked how satisfied they are with their pessary use at 8 months after the initiation of pessary use. Participants can choose one of five graded answers on the Likert scale:
5 Very satisfied 4 satisfied 3 neutral 2 unsatisfied
1 very unsatisfied
Measured: 8 months after start of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
frequency of pessary use, subjective reasons why not to wear a pessary and alternative treatment considerations as assessed by open-ended and yes or no type questions
Measured: 4 months after initiation of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
frequency of pessary use, subjective reasons why not to wear a pessary and alternative treatment considerations as assessed by open-ended and yes or no type questions
Measured: 8 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
Participants will be asked if they experienced side effects that they feel has been caused by pessary use via a custom-made questionnaire: The most commonly anticipated answers have been listed with the option of patients describing other potential adverse events (shown below):
- No side effects
- It feels uncomfortable
- It gives an itchy/burning sensation
- More vaginal discharge
- Other……….
Measured: 4 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
Participants will be asked if they experienced side effects that they feel has been caused by pessary use via a custom-made questionnaire: The most commonly anticipated answers have been listed with the option of patients describing other potential adverse events (shown below):
- No side effects
- It feels uncomfortable
- It gives an itchy/burning sensation
- More vaginal discharge
- Other……….
Measured: 8 months after initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start3 Sep 2021
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjalina Hamerlynck, Principal investigator, UZ GentSteven Weyers, Principal investigator, UZ GentVan Wessel Steffi, Study director, UZ GentAbosi Appeadu Kessewa, Study chair, UZ GentDecalf Veerle, Study chair, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701047
- Sponsor's protocol ID
- BC-08720-ADP
- Status last verified
- Jan 2025
- First submitted
- 2 Dec 2020
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery
- ClinicalTrials.gov ID
- NCT04701047
- Acronym / sponsor ID
- BC-08720-ADP
- Conditions
- Vaginal Prolapse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.
Detailed description
The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.
The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.
The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.
The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pessary | – | Device: vaginal pessaryVaginal prolapse being treated by pessary |
| surgery | – | Procedure: Vaginal prolapse surgeryVaginal prolapse being treated by surgical repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research population will include women above the age of 18 years old who consult the department of urology or the department of gynaecology at the university hospital of Ghent with symptoms of vaginal prolapse. The patients will be recruited by their attending physician. There will be no exclusion on the degree of vaginal prolapse. All symptomatic prolapses will be included in this study. Exclusion criteria will be having undergone a previous treatment with a pessary or surgery for vaginal prolapse, contraindications for surgery or pessary use, active of passive child wish, not able to understand the Dutch language and not able to give a written consent.
Key inclusion criteria (2 listed)
- women with a symptomatic vaginal prolapse
- older than 18 years
Key exclusion criteria (6 listed)
- under 18 years old
- undergone a previous treatment with a pessary or surgery for vaginal prolapse
- contra-indications for surgery or pessary use
- active or passive child wish
- not able to understand the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal pessaryinsertion and follow up of a vaginal pessary | Device | pessary |
| Vaginal prolapse surgerysurgery and follow up after vaginal prolapse surgery | Procedure or surgery | surgery |
Primary outcome
Change in Pelvic Floor Disability Index (PFDI-20)
Time frame: Baseline, 6 weeks, one year, two years, five years
Change in scores on the short-form version of the Pelvic Floor Distress Inventory (PFDI). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.
Change in pelvic floor impact questionnaire (PFIQ-7)
Time frame: Baseline, 6 weeks, one year, two years, five years
Change in scores on the shortened version of the Pelvic Floor Impact Questionnaire (PFIQ). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline, 6 weeks, one year, two years, five years
Change in scores on the short form of the PISQ-31 that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse
6 secondary outcomes
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
Time frame: 4 months after start of therapy
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire
Time frame: 8 months after start of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
Time frame: 4 months after initiation of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire
Time frame: 8 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
Time frame: 4 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire
Time frame: 8 months after initiation of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tjalina Hamerlynck principal investigator
UZ Gent
Steven Weyers principal investigator
UZ Gent
Van Wessel Steffi study director
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Prolapse, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kessewa Abosi-Appeadu (+32 9 332 3774, kessewa.abosiappeadu@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic Floor Disability Index (PFDI-20) (time frame: Baseline, 6 weeks, one year, two years, five years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.